Amryt Pharma PLC (LON:AMYT, NASDAQ:AMYT) said the European Union regulator will now begin the formal review process for its potential treatment for a rare genetic skin disorder with no currently approved treatment.
The European Medicines Agency (EMA) has validated the marketing authorization application for the company’s Oleogel-S10 for the potential treatment of cutaneous manifestations of junctional and dystrophic epidermolysis bullosa in young children and adults.
The review process will take place with the Committee for Medicinal Products for Human Use (CHMP), with an opinion expected to be completed within 210 working days, give or take any ‘clock-stops’ for questions.
The application is supported by data from the company’s pivotal phase 3 trial, as announced in October 2020, where Oleogel-S10 met its primary endpoint of accelerated healing of the target wound by day 45 compared to a control gel.
There is currently no approved treatment for epidermolysis bullosa.
“The validation of the Oleogel-S10 MAA marks another important milestone for Amryt as we progress our lead development candidate Oleogel-S10 with the regulatory authorities in both Europe and the US,” said Dr Joe Wiley, chief executive of Amryt Pharma.
“Today’s news also represents a potentially important advancement for patients and families living with this rare and distressing disorder. We will continue to work closely with the respective regulatory authorities with the hope of bringing Oleogel-S10 to patients as soon as possible.”